UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetics study of food ingredient. SWE-2018-03-HR1002
Title of the study (Brief title)	Pharmacokinetics study of food ingredient.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the pharmacokinetics of food ingredient.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum observed plasma concentration, Area under the plasma concentration-time curve from time zero to the time of the last measurable drug concentration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of test food 1->Washout (12days or more)->Single ingestion of test food 2.
Interventions/Control_2	Single ingestion of test food 2->Washout (12days or more)->Single ingestion of test food 1.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Male and Female whose age are 20 <= years old <65. (2)Subjects who are able to submit the written informed consents.
Key exclusion criteria	(1)Subjects who are with treatment. (2)Subjects who are with history of gastrointestinal surgery. (3)Subjects who are attending other studies or attended other studies within the past 4 weeks. (4)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods. (5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody, HIV antigen/antibody or HTLV-1 antibody test. (6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	16

Research contact person
Name of lead principal investigator	Takao Tanaka
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0590
Email	Takao_Tanaka@suntory.co.jp

Public contact
Name of contact person	Namino Tomimori
Organization	SUNTORY WELLNESS LIMITED
Division name	Institute for Health Care Science
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0651
Homepage URL
Email	Namino_Sugiura@suntory.co.jp

Sponsor
Institute	SUNTORY WELLNESS LIMITED
Institute
Department

Funding Source
Organization	SUNTORY WELLNESS LIMITED
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 12 Day
Anticipated trial start date	2018 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 22 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037752